MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION ORG-9110A; MULTIPLE PATIENT RECEIVER

Model Number ORG-9110A

Device Problems Signal Artifact/Noise (1036); Communication or Transmission Problem (2896); Incomplete or Inadequate Connection (4037)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/19/2021

Event Type  malfunction  

Manufacturer Narrative

The biomedical engineer reported that the multiple patient receiver (org) is having a significant amount of signal loss with their remote telemetry.One patient had a very long pause alarming for asystole and then lost signal, once signal was regained, the patient was back in sinus rhythm.Another patient had a signal loss for about 20 minutes.The biomedical engineer reboot teles and swapped batteries but the unit usually resolves issue on it's own.No patient injury reported.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 when additional information becomes available.Manufacturer references file (b)(4).

Event Description

The biomedical engineer reported that the multiple patient receiver (org) is having a significant amount of signal loss with their remote telemetry.One patient had a very long pause alarming for asystole and then lost signal, once signal was regained, the patient was back in sinus rhythm.Another patient had a signal loss for about 20 minutes.The biomedical engineer reboot teles and swapped batteries but the unit usually resolves issue on it's own.No patient injury reported.

Manufacturer Narrative

The biomedical engineer reported that the multiple patient receiver (org) is having a significant amount of signal loss with their remote telemetry.One patient had a very long pause alarming for asystole and then lost signal, once signal was regained, the patient was back in sinus rhythm.Another patient had a signal loss for about 20 minutes.The biomedical engineer rebooted the telemetry devices and swapped batteries but the unit usually resolves issue on its own.No patient injury reported.Investigation summary: nihon kohden sent on site support to resolve the issue of signal loss.The on-site representative troubleshot the issue and replaced amplifiers and broadband splitters and issue resolved.This would indicate that the issue of signal loss was due to either improper set up or environmental conditions at the facility that prevented to the system from operating as intended.No further issues were reported.The root cause of signal loss is related to either improper set up or environmental factors,as such, capa is not warranted.Additional data narrative: b4: date of this report g3: date received by manufacturer g6: type of report h2: if follow-up, what type? h4: device manufacturer date h6: event problem and evaluation codes h10: additional manufacturer narrative.

Event Description

The biomedical engineer reported that the multiple patient receiver (org) is having a significant amount of signal loss with their remote telemetry.One patient had a very long pause alarming for asystole and then lost signal, once signal was regained, the patient was back in sinus rhythm.Another patient had a signal loss for about 20 minutes.The biomedical engineer rebooted telemetry devices and swapped batteries but the unit usually resolves issue on it's own.No patient injury reported.

• Brand Name: ORG-9110A
• Type of Device: MULTIPLE PATIENT RECEIVER
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; 1-31-4 nishiochia; attn: shama mooman; shinjuku-ku, tokyo 161-8 560; JA 161-8560
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; 1-1 tajino; attn: shama mooman; tomioka city, gunma 370-2 314; JA 370-2314
• Manufacturer Contact: shama mooman ; safety mgmt dept, quality mgmt; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 11829474
• MDR Text Key: 279596220
• Report Number: 8030229-2021-00286
• Device Sequence Number: 1
• Product Code: DRG
• UDI-Device Identifier: 04931921103906
• UDI-Public: 04931921103906
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 06/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ORG-9110A
• Device Catalogue Number: ORG-9110A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2021
• Initial Date FDA Received: 05/14/2021
• Supplement Dates Manufacturer Received: 05/31/2022
• Supplement Dates FDA Received: 06/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: ZM TRANSMITTERS; ZM TRANSMITTERS